Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-000503-87
    Sponsor's Protocol Code Number:PAT15-PCODD
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-05-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2016-000503-87
    A.3Full title of the trial
    A multicentre, Phase III, randomised, double blind, placebo-controlled study to assess the safety and the efficacy of a weekly administered dose of 30,000 IU vitamin D (colecalciferol) in deficient patients diagnosed with PCOS
    Multicentrikus, randomizált, placebo-kontrollált klinikai vizsgálat a heti 30.000 NE D-vitamin (kolekalciferol) kezelés hatásosságának és biztonságosságának meghatározására D-vitamin hiányos és policisztás ovárium szindrómával (PCOS) diagnosztizált betegek körében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Weekly 30000 IU vitamin D treatment in PCOS patients
    Heti 30000 NE D-vitamin kezelés PCOS betegeknél
    A.4.1Sponsor's protocol code numberPAT15-PCODD
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPharma Patent Kft
    B.1.3.4CountryHungary
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharma Patent Kft
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharma Patent Kft
    B.5.2Functional name of contact pointIroda-törzskönyvezés
    B.5.3 Address:
    B.5.3.1Street AddressNépfürdő utca 22 Duna Torony B épület, 10.em
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1138
    B.5.3.4CountryHungary
    B.5.4Telephone number+361630 61 82
    B.5.5Fax number+361630 25 60
    B.5.6E-mailclinical@pharmapatent.eu
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vitamin D3 Pharma Patent 30000 NE filmtabletta
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Patent Kft
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLECALCIFEROL
    D.3.9.3Other descriptive namekolekalciferol
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vitamin D deficient female subjects diagnosed with PCOS
    D-vitamin hiányos PCO szindrómával diagnosztizált nőbeteg
    E.1.1.1Medical condition in easily understood language
    female subjects with low Vitamin D levels and diagnosed with PCOS
    Alacsony D-vitamin vérszintű PCOS betegek
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10047626
    E.1.2Term Vitamin D deficiency
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy is consider as reveal of ovarian dysfunction based on progesterone levels and menses diary.
    Az ovariális ciklus rendeződése (az esetek legalább 20%-ban az ovulációra utaló paraméterek mérésésén keresztül) a vizsgálati készítmény hatásának megítélésére a placeboval-kezelt csoporttal összehasonlítva.
    E.2.2Secondary objectives of the trial
    - Efficacy and safety of orally administered vitamin D treatment by the changes in 25(OH) D levels.
    - Changes in Ovarian – morphology based on results of standard TVUS Imaging
    - All AE detected during treatment and follow-up period compared to placebo group.
    - A heti adagolású D-vitamin kiegészítő alkalmazásának hatásossága a 25(OH)D szint mérésen keresztül összehasonlításban a bázis időszak értékeihez képest.
    - Az ovarium PCO- morfológia változása UH kép alapján
    - A vizsgálat időtartama alatt észlelt mellékhatások regisztrálása és azonosítása a gyakoriság, az eloszlás és kezelési csoportok szerint.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female subject age >18 years at the time of informed consent.
    2. Clinical and/or biochemical hyperandrogenism and the proven PCOS by the “Rotterdam” criteria, (ovarian dysfunction, oligo- and/or anovulation, and the morphology of polycystic ovaries on ultrasound images when other etiologies are excluded)
    3. 25(OH)D levels <21ng/ml by inclusion
    4. Subject can not be under any kind of hormone or metphormine therapies and no indication that requires continuation.
    5. Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures
    1. életkor szerint 18 év feletti nőbetegek;
    2. hiperandrogenizmus fenállása mellett a „Rotterdam” kritériumok alapján igazolt PCOS fenállása (ovariális diszfunkció: oligo- és/vagy anovuláció, és /vagy policisztás ovarium morfológia UH képe, minden más aetiologia kizárása mellett);
    3. bevonáskor 25(OH)D szint < 21 ng/ml;
    4. a beteg nem áll hormonterápia, illetve metformin kezelés alatt, és/vagy a kezelés folytatása nem indokolt és elhagyható;
    5. a vizsgálatra vonatkozó betegtájékoztatáson résztvett, a részvételt elfogadta és beleegyezési nyilatkozatot sajátkezűen aláírta.
    E.4Principal exclusion criteria
    1. Has been exposed to any investigational agent within 3 month of enrolment to the study
    2. Sever metabolic disease on endorcrine disease in etiology different from PCOS
    3. -Significant obesity (BMI> 36)
    4. Any other other signs of lab results that may lead to other etiologies in differentiation
    5. Increased serum calcium level results or symptoms of hypercalcemia in last one year
    6. Hypercalciuria or kidney stone appearance in last one year
    7. Sever kidney diseases (CKD 3 or higher)
    8. -Chronic or serious disease, which can significantly influence the absorption, metabolism of vitamin D or Ca
    9. Heart failure or angina pectoris,
    10. More than 1000 IU vitamin D per day intake or in total >3000 IU per week within 1 month prior to trial (in any forms medication, or nutritional food supplement)
    11. The patient is under hormonal therapy for the aim of ovulation stimulation or was involved in within 3 months prior the study
    12. Existence or suspected gravidity
    13. Any other finding or symptoms which are by the opinion of the Investigator may indicate a potential interference with the safety of participating trial subjects
    14. Has a known hypersensitivity to any of the investigational drug or vehicle components.
    15. Concomitant medication which is not allowed:
    1. más vizsgálati készítménnyel történt kezelés a beválasztást megelőző 3 hónapban
    2. súlyosfokú a PCOS-től eltérő aetiológiájú endokrin- vagy anyagcserebetegség;
    3. jelentős mértékű obesitas, (BMI >36);
    4. a differenciáldiagnózisban érintett más betegségekre utaló jelek vagy laboreredmények;
    5. emelkedett szérum calcium labor eredmények vagy hypercalcaemia tüneteinek jelentkezése az elmúlt egy év alatt;
    6. hypercalciuria vesekövesség jelentkezése az elmúlt év alatt,
    7. súlyosfokú vesebetegség (CKD 3 vagy súlyosabb)
    8. krónikusan fenálló vagy súlyos betegség, ami jelentős mértékben befolyásolhatja a felszívódást, a D-vitamin metabolizmust vagy a Ca anyagcserét;
    9. szívelégtelenség vagy angina pectoris,
    10. a vizsgálatot megelőző 1 hónapon belül alkalmazott napi 1000 NE-t, illetve a heti 3000 NE összdózist meghaladó D-vitamin bevitel (gyógyszer, gyógytápszer vagy táplálékkiegészítő bármelyik formájában)
    11. ha a beteg beválasztáskor illetve az azt megelőző 3 hónapban részt vett ovuláció-serkentés vagy IVF célú hormonális terápiában;
    12. graviditás fennállása vagy annak gyanúja
    13. egyéb más lelet, mely a vizsgálóorvos megítélése szerint interferálhat a beteg biztonságos részvételéve;
    14. ismert hypersensitivitás a vizgsálati készítmény hatóanyagára vagy összetevőire
    15. Az együtt nem rendelhető gyógyszerek folyamatos szedése:
    E.5 End points
    E.5.1Primary end point(s)
    Regularity of ovarian function in at least 20% of subjects, detected by changes in progesterone levels and menses diary.
    Ovarialis diszfunkció (ovuláció) rendeződése a progesteron értékek és a menses-naptár adatai alapján a kezelt esetek legalább 20%-ban
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluated on the 12 weeks and 24 weeks
    A 12. és a 24. héten értékelve
    E.5.2Secondary end point(s)
    Safety endpoints:
    - Registration and identification of adverse events (included clinically significant lab abnormalities), by frequency and comparative analysis of distribution compared to placebo-treated patients
    - Changes in serum calcium, urinary calcium / creatinine ratio compared to the base and the control group as safety parameters.
    Efficacy analysis:
    - Evaluation of treatment of changes in 25 (OH) D blood levels compared between treatment groups
    - Change of endocrine parameters also of blood glucose and HgbA1c values effected by treatment between the groups and compared to the base, and the evaluation stratified by the 25OHD levels.
    - Changes in ovarian morphology assessed by TVUS imaging and compared between groups
    Biztonságossági (safety) paraméterek:
    - A kezelés időtartama alatt észlelt nem várt események, (beleértve a jelentősnek minősített laboratóriumi eltéréseket is) regisztrálása és azonosítása, a gyakoriság és az eloszlás szerinti összehasonlító elemzése a placeboval kezelt csoporthoz képest.
    - Serum kalcium, vizelet kalcium/ kreatinin arány változása a bázishoz és kontrollcsoporthoz képest, mint biztonságossági parameter.
    Hatásossági (efficacy) paraméterek:
    - A D-vitamin kezelés hatásosságának értékelése a 25(OH)D vérszint változása alapján, csoportonkénti összehasonlítással.
    - A vizsgált endokrin paraméterek, valamint a vércukor és a HgbA1c értékeinek változása a kezelés hatására a bázisértékhez és a csoportok közötti különbséghez viszonyítva, továbbá változásuk az elért 25(OH)D vérszint alapján sztratifikálva.
    - UH kép alapján a PCO-morfológia változás csoportonként
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy Evaluated on the 12 weeks and 24 weeks ,
    Safety on the weeks 6, 12 18 and 24.
    Hatásosság a 12. és a 24. héten értékelve
    Biztonásgosság a 6. 12. 18. és a 24. héten értékelve
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    kettősvak randomizált fázis után egy nyilt kezelési fázis
    Duble blind randomised phase followed by an open label phase
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 168
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state168
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-06
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Jul 27 04:02:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA